CapnoSpot™ Pneumothorax Decompression Indicator
K-Number: K223625 · 2023-03-28
ApplicantPneumeric, Inc.
Decision Date2023-03-28
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
CapnoSpot™ Pneumothorax Decompression Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Pneumeric, Inc.. It received FDA 510(k) clearance on 2023-03-28 under 510(k) number K223625. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CapnoSpot™ Pneumothorax Decompression Indicator?
CapnoSpot™ Pneumothorax Decompression Indicator is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is Pneumeric, Inc.. The 510(k) number is K223625.
When did CapnoSpot™ Pneumothorax Decompression Indicator receive FDA 510(k) clearance?
CapnoSpot™ Pneumothorax Decompression Indicator received FDA 510(k) clearance on 2023-03-28, under 510(k) number K223625.
Who is the listed applicant for CapnoSpot™ Pneumothorax Decompression Indicator?
The FDA 510(k) record lists Pneumeric, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CapnoSpot™ Pneumothorax Decompression Indicator?
The FDA product code for CapnoSpot™ Pneumothorax Decompression Indicator is GAA.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.